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Computer Software Assurance (CSA) – Operational GxP Guide

Computer Software Assurance (CSA) – Operational GxP Guide

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€99,00 EUR
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Computer Software Assurance (CSA) is the risk-based approach promoted by the FDA for the validation of GxP software, based on the principle “Assurance over Documentation.”

This operational guide shows how to apply CSA in a practical way, moving beyond the traditional CSV model and transforming regulatory requirements into operational activities, risk-proportionate testing, and audit-ready documentation.

What you will find in the guide

  • CSA regulatory framework (FDA, Annex 11, GAMP 5, ICH Q9)
  • Differences between traditional CSV and CSA
  • Risk assessment and functionality classification
  • Scripted and exploratory testing in line with CSA
  • Evidence management and audit readiness
  • Application to Cloud and SaaS systems

Target audience
QA, CSV/CSA Managers, IT, Validation, Regulatory Affairs, and QP.

Product details

Format: Professional PDF

Pages: 120 pages

Updated to: January 2026

Languages: ITA – ENG

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DECLARED REGULATORY BASIS

Built on the most up-to-date official sources.

Every guide is built from the official sources current at the editorial verification date stated in the document. The editions, revisions and cut-off dates used are declared and checked again for every new release; requirements are kept distinct from GuideGxP operational interpretation.

Main references for this guide FDA CSA guidance (2026) · 21 CFR Part 11 · EU GMP Annex 11
  • Editions and revisions stated in the document
  • Explicit editorial verification date
  • Requirements separated from practical recommendations

GuideGxP is an independent publisher and is not affiliated with, approved by or sponsored by the authorities and organisations cited.

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Every new release is delivered automatically by email.

Buy once: whenever we publish a new release of the guide you purchased, it is sent automatically to the email address used for the order, together with the download link. No request, new registration or additional payment is required.

  • Every future release included for life
  • Automatic delivery to the order email
  • Average review cycle: 6 months

Timing may vary with regulatory and technical developments. No action is required after purchase; simply use a valid email address at checkout.

FREQUENTLY ASKED QUESTIONS

Everything you need to know before purchasing.

Clear information about downloads, formats, languages and the use of GuideGxP resources.

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When available, you can open the preview free of charge using the buttons on the product page to review its structure, level of detail and operational approach.

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